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The Food and Drug Administration has approved Stivarga (regorafenib) to treat patients with metastatic colorectal cancer that has progressed after treatment. The drug is a multi-kinase inhibitor that blocks several enzymes involved in cancer growth.

“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients' lives and is the second drug approved for patients with colorectal cancer in the past two months,” Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release.

The drug was reviewed under the FDA's priority review program, which provides an expedited six-month review for drugs deemed to offer major advances in treatment or that provide treatment when no adequate therapy exists. Stivarga was approved one month ahead of the goal date of October 27.

The approval was based on the results from the pivotal Phase III CORRECT (“Colorectal cancer treated with regorafenib or placebo after failure of standard therapy”) trial, which showed an increase in overall and progression-free survival compared with placebo in patients with metastatic colorectal cancer that had progressed after approved standard therapies. Both groups of patients also received best supportive care to help manage side effects and symptom.

The results showed:

* Patients treated with Stivarga plus best supportive care lived a median of 6.4 months compared with a median of five months in patients treated with placebo plus best supportive care, and

* Patients treated with Stivarga plus best supportive care had a progression-free median survival time of two months compared with 1.7 months in patients receiving placebo plus best supportive care.

“The approval of regorafenib adds to the treatments we have for metastatic colorectal cancer, which is important for those patients who have no further options,” Heinz-Josef Lenz, MD, a CORRECT investigator and Co-leader of the Gastrointestinal Cancers Program at USC Norris Comprehensive Cancer Center, said in a news release. “The drug provides patients with another avenue to fight this cancer.”

Stivarga will include a Boxed Warning alerting patients and health care professionals that severe and fatal liver toxicity occurred in patients receiving the drug in clinical trials. The most commonly reported side effects were weakness/fatigue, loss of appetite, hand-foot syndrome, diarrhea, mucositis, weight loss, infection, high blood pressure, and dysphonia voice changes.

Stivarga was developed by Bayer Healthcare Pharmaceuticals, which last year entered into an agreement with Onyx Pharmaceuticals under which Onyx will receive a royalty on any future global net sales of the agent in oncology. The two companies are jointly promoting Stivarga in the United States.

Other recent FDA approvals for adults with metastatic colorectal cancer include Zaltrap for use in combination with FOLFIRI chemotherapy.

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